Methods, devices, and systems for percutaneously anchoring annuloplasty rings

ABSTRACT

Apparatus, systems, and methods are provided for percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves. An annuloplasty ring includes an outer tube, an inner body member, and an anchor deployment system. The outer tube includes a plurality of windows and has an axis along its length. The internal body member includes a plurality of anchors formed perpendicular to the axis. The anchor deployment system selectively rotates the internal body member with respect to the axis of the outer tube. The rotation deploys the plurality of anchors through the plurality of windows.

RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. § 119(e) of U.S.Provisional Patent Application No. 61/734,904, filed Dec. 7, 2012,titled “ROTATIONAL BARBS,” and is a continuation-in-part of U.S. patentapplication Ser. No. 13/779,478, filed Feb. 27, 2013, titled“PERCUTANEOUS ANNULOPLASTY SYSTEM WITH ANTERIOR-POSTERIOR ADJUSTMENT,”which claims the benefit under 35 U.S.C. § 119(e) of U.S. ProvisionalPatent Application No. 61/604,856, filed Feb. 29, 2012, titled“PERCUTANEOUS ANNULOPLASTY SYSTEM WITH ANTERIOR POSTERIOR ADJUSTMENT,”and of U.S. Provisional Patent Application No. 61/734,904, each of whichis hereby incorporated by reference herein in its entirety.

TECHNICAL FIELD

The present disclosure relates to treating and repairing heart valves,and specifically to apparatus, systems, and methods for percutaneoustranscatheter repair of heart valves. Disclosed embodiments includeadjustable annuloplasty rings that are configured to be deliveredthrough a catheter and percutaneously anchored to a heart valve annulus.

BACKGROUND INFORMATION

Heart valve defects, such as regurgitation, may be caused by arelaxation of the tissue surrounding a heart valve (e.g., the mitralvalve or tricuspid valve). This causes the valve opening to enlarge,which prevents the valve from sealing properly. Such heart conditionsare commonly treated by a procedure during which an annuloplasty ring isfixed or secured to the annulus of the valve. Cinching or securing thetissue of the annulus to the annuloplasty ring can restore the valveopening to its approximate original size and operating efficiency.

Typically, annuloplasty rings have been implanted during open heartsurgery, so that the annuloplasty ring can be sewn into the valveannulus. Open heart surgery is a highly invasive procedure that requiresconnecting a heart and lung machine (to pump the patient's blood andbreathe for the patient), stopping the patient's heart, and cutting openthe thoracic cavity and heart organ. The procedure can expose thepatient to a high risk of infection and may result in a long anddifficult recovery. The recovery can be particularly difficult forpatients in less than optimal health due to the effects of sufferingfrom a heart valve defect such as regurgitation.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a top view an internal body member of an annuloplasty ring inan operative geometry according to certain embodiments.

FIG. 1B is a perspective view of the internal body member shown in FIG.1A.

FIG. 1C is a side view of the internal body member shown in FIG. 1A inan elongated geometry.

FIG. 2 is a schematic diagram of a cutting pattern used to form theinternal body member shown in FIG. 1A according to certain embodiments.

FIG. 3 is a perspective view of a body member and a device closure of anannuloplasty ring according to certain embodiments.

FIG. 4A is a perspective view of an anchor deployment system accordingto certain embodiments.

FIG. 4B is an enlarged view of the anchor deployment system shown inFIG. 4A.

FIG. 4C is a perspective view of the anchor deployment system shown inFIG. 4A in a partially retracted state.

FIG. 4D is an enlarged view of the anchor deployment system shown inFIG. 4C.

FIG. 4E is a perspective view of the anchor deployment system shown inFIG. 4A in a retracted state.

FIG. 4F is an enlarged view of the anchor deployment system shown inFIG. 4E.

FIG. 5A is a perspective view of a retaining cover used in an anchordeployment system according to certain embodiments.

FIG. 5B is a perspective view of a body member within the retainingcover shown in FIG. 5A according to certain embodiments.

FIG. 5C is an enlarged view of the retaining cover of and body membershown in FIG. 5B.

FIG. 5D illustrates the retaining cover shown in FIG. 5C after rotatingthe body member to deploy an anchor.

FIG. 6 is a perspective view of an annuloplasty ring including an anchordeployment system according to certain embodiments.

FIG. 7A is a perspective view of annuloplasty ring including anotheranchor deployment system according to certain embodiments.

FIG. 7B is a perspective view of a rotation member for use in the anchordeployment system shown in FIG. 7A according to certain embodiments.

FIG. 7C is a perspective view of another rotation member for use in theanchor deployment system shown in FIG. 7A according to certainembodiments.

FIG. 7D is an enlarged perspective view of the annuloplasty ringincluding the anchor deployment system shown in FIG. 7A.

FIG. 7E is a cross-sectional, perspective view of the annuloplasty ringincluding the anchor deployment system shown in FIG. 7A.

FIG. 8A is top view of an annuloplasty ring in an operative geometryaccording to certain embodiments.

FIG. 8B is a schematic diagram of a cutting pattern used to form theannuloplasty ring shown in FIG. 8A according to certain embodiments.

FIG. 9A is a simplified schematic diagram illustrating a top view ofinternal anchor ribbons according to certain embodiments.

FIG. 9B is a simplified schematic diagram illustrating a side view ofthe internal anchor ribbons shown in FIG. 9A according to certainembodiments.

FIG. 9C is a simplified schematic diagram illustrating an overlappingside view of the internal anchor ribbons shown in FIG. 9B.

FIG. 9D is a simplified schematic diagram illustrating a top view of aglide ribbon according to certain embodiments.

FIG. 9E is a simplified schematic diagram illustrating a side view ofthe glide ribbon shown in FIG. 9D.

FIG. 10A is a simplified schematic diagram illustrating across-sectional side view of an annuloplasty ring before anchordeployment according to certain embodiments.

FIG. 10B is a simplified schematic diagram illustrating across-sectional side view of an annuloplasty ring during anchordeployment according to certain embodiments.

FIG. 10C is a simplified schematic diagram illustrating across-sectional side view of an annuloplasty ring after anchordeployment according to certain embodiments.

FIG. 10D is a perspective view of a portion of an annuloplasty ringafter anchor deployment according to certain embodiments.

FIG. 11A is a perspective view of an annuloplasty ring with separatelydeployable anchor members with the anchors in an introductionconfiguration according to certain embodiments.

FIG. 11B is a perspective view of a separately deployable anchor memberaccording to certain embodiments.

FIG. 11C is a perspective view of a pair of separately deployable anchormembers according to certain embodiments.

FIG. 11D is a perspective view of an annuloplasty ring with separatelydeployable anchor members with the anchors in a deployed configurationaccording to certain embodiments.

FIG. 12A is a perspective view of an annuloplasty ring withindependently deployable anchor members before anchor deploymentaccording to certain embodiments.

FIG. 12B is a perspective view of an annuloplasty ring withindependently deployable anchor members during anchor deploymentaccording to certain embodiments.

FIG. 12C is a perspective view of an annuloplasty ring withindependently deployable anchor members during anchor deploymentaccording to certain embodiments.

FIG. 12D is a perspective view of an annuloplasty ring withindependently deployable anchor members after anchor deploymentaccording to certain embodiments.

FIG. 13 illustrates various anchor shapes that may be used with thedisclosed annuloplasty rings according to certain embodiments.

FIG. 14 illustrates various anchor designs that may be used with thedisclosed annuloplasty rings according to certain embodiments.

FIG. 15A is a schematic diagram illustrating a trans-septal approach forendovascular delivery of an annuloplasty ring to the mitral valve of aheart according to one embodiment.

FIG. 15B is a schematic diagram illustrating an example retrogradeapproach of an annuloplasty ring to the mitral valve of a heartaccording to another embodiment.

FIG. 15C is a schematic diagram illustrating an example trans-apicalapproach of an annuloplasty ring to the mitral valve of a heartaccording to another embodiment.

FIG. 16A is a perspective view of an annuloplasty ring in the elongateinsertion geometry and partially deployed from the distal end of adelivery catheter in a first deployment stage according to certainembodiments.

FIG. 16B is a perspective view of an annuloplasty ring in a second stageof partial deployment from the delivery catheter.

FIG. 16C is a perspective view of an annuloplasty ring in a third stageof deployment from the delivery catheter.

FIG. 16D is a perspective view of an annuloplasty ring 1602 in a fourthstage of deployment.

FIG. 17A is a flowchart for a method for repairing a defective heartvalve according to certain embodiments.

FIG. 17B is a flowchart for a method for repairing a defective heartvalve according to certain embodiments.

FIG. 18 is a flowchart for a method for repairing a defective heartvalve according to certain embodiments.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

While there are flexible rings currently on the market, surgeonsgenerally prefer rigid and semi-rigid rings for valve repair to treatischemic and functional mitral valve regurgitation. Rigid and semi-rigidrings, unfortunately, do not lend themselves to being delivered into theheart through a catheter. The present disclosure provides systems andmethods for repairing heart valves through percutaneous transcatheterdelivery and fixation of annuloplasty rings to heart valves. Theembodiments of annuloplasty rings can be configured in both an elongateinsertion geometry that can be inserted into a catheter tube and anoperable geometry providing a curved and rigid or semi-rigid annularshape.

In certain embodiments, an annuloplasty ring is delivered percutaneouslyto the mitral and/or tricuspid valve annulus of the heart. The disclosedembodiments apply, for example, to trans-septal, retrograde, ortrans-apical approaches for delivering annuloplasty rings to an annulusof a heart valve. For delivery of rings into the mitral valve,percutaneous delivery may use a retrograde approach from the femoralartery, an antegrade approach via a trans-septal entry, or atrans-apical approach through the base or apex of the heart through theleft ventricle to the left atrium. Delivery of rings to the tricuspidvalve may include an approach from the inferior or superior vena cava.

Certain annuloplasty rings disclosed herein are small and flexibleenough to be percutaneously delivered, but can be put into a rigid orsemi-rigid ring shape and then securely anchored into the heart valveannulus without having to open up the chest. Disclosed embodimentsinclude segmented annuloplasty rings, delivery systems, and methods foranchoring and cinching the annuloplasty ring around the valve annulus.

Example Ring Embodiments with Radial, Rotational Anchors

FIGS. 1A and 1B are top and perspective views, respectively, of aninternal body member 100 of an annuloplasty ring in an operativegeometry according to certain embodiments. The internal body member 100includes a hypotube 102 cut to include a plurality of anchors 104 andone or more expansion regions 106. As discussed below, the hypotube 102may be cut in a pattern (e.g., a crisscross pattern), including in theexpansion regions 106, for expansion and compression of the annuloplastyring to allow transformation from a straight configuration in a deliverysystem to the operative geometry (e.g., D-shaped or C-shaped) at adelivery site within a heart. The expansion regions 106 may also allowthe internal body member 100 to expand when within the heart so that theanchors 104 may be deployed into the heart valve annulus. After anchordeployment in such embodiments, the internal body member 100 is allowedto contract, which reduces the circumference of the heart valve annulusand reduces regurgitation. The internal body member 100 is configured toenable percutaneous, transcatheter annuloplasty to repair a heart valve.The internal body member 100 may be fastened, percutaneously, to theannulus of the heart valve while in the expanded state and then reducedto the contracted state to decrease an A-P distance of the target valveand thereby improve leaflet coaptation of the target valve and reduceregurgitation through the target valve.

In FIGS. 1A and 1B, as well as in other embodiments disclosed herein,the internal body member 100 may be arranged in a “D-shape” in theoperable geometry (e.g., when implanted around the annulus). TheD-shaped body member 100 has a certain geometrical ratio that is inconformance with the anatomical geometry of the annulus of the humanmitral or tricuspid valve. For example, in certain embodiments the ratioof the A-P distance to the commissure-commissure (C-C) distance of theinternal body member 100 when implanted (i.e., in the contracted state)is in a range between about 0.60 and about 0.70. In one embodiment, theimplanted ratio of the A-P distance to the C-C distance is about 0.62.

In addition to the operable geometry, the internal body member 100 maybe placed in an elongate insertion geometry such that the internal bodymember 100 can be inserted through a catheter into the heart. Asdiscussed in detail below, in certain embodiments, the hypotube 102 maycomprise a shape memory (e.g., Nitinol) hypotube into which a particularpattern is laser cut to form the device features, such as the expansionregion 106 and/or anchors 104. The shape memory hypotube 102 is heat setto a “memorized” annular shape (e.g., the D-shaped operable geometry).The shape memory hypotube 102 is superelastic such that applyingsufficient stress places the internal body member 100 into the elongateinsertion geometry and releasing the stress allows the internal bodymember 100 to resume the D-shaped operable geometry. Although theillustrated embodiment of an internal body member 100 of FIG. 1A has aD-shaped operable geometry, artisans will recognize from the disclosureherein that other annular-shaped operable geometries may also be used.For example, circular, oval, or C-shaped operable geometries may beused.

The plurality of anchors 104 are configured to secure the internal bodymember 100 to the annulus of the heart valve. In certain embodiments,the anchors 104 are sufficient such that additional suturing of theannuloplasty ring to the valve annulus is not needed. In FIGS. 1A, 1B,and 1C, the anchors 104 are curved in the illustrated deployedconfiguration. The anchors 104 may be cut from the side of hypotube 102.When the anchors are first cut, they lie in the radial plane of theshape memory hypotube 102 and are concentric with the hypotube 102. Theanchors 104 are then heat-set to the curved, deployed configuration. Asshown in FIG. 1B, the heat-set anchors curve away from the hypotube 102.The heat-set anchors 104 may curve in the opposite direction from thecurvature of the hypotube 102. For example, if newly cut anchors curveto the right, heat-set anchors would curve to the left. Although FIGS.1A, 1B, and 1C show curved anchors 104, anchors in other embodiments mayinclude other shapes, such as linear or helical deployed configurations.In certain embodiments, the anchors 104 include a shape memory material(e.g., Nitinol) that is heat set to a deployed configuration (e.g.,linear, helical, or curved configuration shown in FIG. 1B). Artisanswill recognize from the disclosure herein that combinations of barbdesigns and/or deployed configurations may also be used.

In some embodiments, the anchors 104 are superelastic such that applyingsufficient stress places the anchors 104 into an introductionconfiguration and releasing the stress allows the anchors 104 to resumetheir respective deployed configurations. In certain embodiments, theanchors 104 lay in-line with the curvature of the internal body member100 when in the introduction configuration to facilitate insertion ofthe internal body member 100 through the catheter. In such embodiments,the anchors 104 may be selectively deployed at a desired time (e.g.,after the internal body member 100 is properly positioned against theannulus of the heart valve). The superelastic property of the anchors104, combined with the opposite-curvature of the anchors in theintroduction and deployed configurations, is used to self-propel theanchors 104 into the annulus of the heart valve. The opposite curvatureof the anchors in the introduction and deployed configurations causesthe anchors 104 to spring into tissue with extra force. In addition, orin other embodiments, an operator (e.g., a surgeon) applies a mechanicalforce to the internal body member 100 to propel the anchors 104 into theannulus of the heart valve.

The hypotube 102 includes one or more through holes 110, 112 at each endto allow one or more pins (not shown) to couple the male and femalecomponents of a device closure to respective ends of the hypotube 102.The hypotube 102 may also include a control window that allows one ormore lines or sutures to exit the hypotube 102. The lines or sutures areused to snap lock the internal body member 100 into a ring shape and/orto deploy the anchors 104.

In FIG. 1C, the internal body member 100 is shown in the elongateinsertion geometry. It should be noted, however, that the anchors 104 inFIG. 1C are shown in the extended (deployed) position, and not in aconfiguration suitable for insertion through a catheter. As discussedbelow, the internal body member 100 is formed from a straight (elongate)hypotube into which features, such as anchors 104, may be formed.

In addition to the operable geometry shown in FIGS. 1A and 1B theinternal body member 100 is capable of making the transition from anelongate insertion geometry (FIG. 1C) to the annular operable geometry(FIGS. 1A and 1B). The elongate insertion geometry allows the internalbody member 100 to be inserted into and passed through a catheter forpercutaneous passage of the annuloplasty ring 600 into the heart of apatient. A transition from an elongate insertion geometry to an annularoperable geometry is illustrated in FIGS. 16A, 16B, 16C, and 16D, anddiscussed below with reference to the same.

Although not shown in FIGS. 1A, 1B, and 1C, certain ring embodiments mayinclude a selectively adjustable member for changing the size and/orshape of the internal body member 100 postoperatively to compensate forchanges in the size of the heart and/or the treated heart valve.Examples of a selectively adjustable member are provided in U.S. patentapplication Ser. No. 13/198,582, filed Aug. 4, 2011, and titledPERCUTANEOUS TRANSCATHETER REPAIR OF HEART VALVES, which is herebyincorporated by reference herein in its entirety.

FIG. 2 is a schematic diagram of a cutting pattern 200 used for laserprocessing hypotubes, such as the hypotube 102 shown in FIGS. 1A, 1B,and 1C. The cutting pattern 200 corresponds to the entire hypotube 102as if the hypotube 102 were cut along a longitudinal axis and unrolled.Thus, for example, each expansion region 106 shown in FIG. 1C is shownin FIG. 2 as being split between a first half of the expansion region208 a and a second half of the expansion region 208 b.

The cutting pattern 200 defines the configuration of a hypotube (e.g.,hypotube 102) and defines how regions of the hypotube (e.g., expansionregions 106) interact with adjacent regions as the hypotube transitionsfrom an elongate insertion geometry (see e.g., FIG. 1C) to an annularoperable geometry (see e.g., FIGS. 1A and 1B). As shown in FIG. 2, thecutting pattern 200 in this example embodiment includes a “crisscross”pattern 202. The crisscross pattern 202 allows for increased expansionand/or contraction in regions of the hypotube containing the crisscrosspattern 202. One or more rigid regions 204, semi-rigid regions 206, andexpansion regions 208 may be defined using the crisscross pattern 202.The rigid region 204 does not include the crisscross pattern 202. Thesemi-rigid region 206 includes an intermittent crisscross pattern 202.The crisscross pattern 202 is throughout the expansion region 208. Theexpansion region 208 may also include large gaps or cutout regions 209to allow increased flexibility or bending of the internal body member(e.g., at the corners of the D-shape as shown in FIG. 1B at theexpansion regions 106). The cutting pattern 200 also includes anchorcutouts 210, control window cutouts 212, and through hole cutouts 214.The anchor cutouts 210 define the length, width, and location ofannuloplasty ring anchors, such as anchors 104. Similarly, the controlwindow cutouts 212 and through hole cutouts 214 define the size,geometry, and location of control windows and through holes in thehypotube. The cutting pattern 200 defines the annular operable geometryof a hypotube, allows the hypotube to easily transition from theelongate insertion geometry to the annular operable geometry, and allowsfor adjustment in the anterior-posterior (A-P) dimension to ensure thatthe annulus is sufficiently reduced.

FIG. 3 is a perspective view of a body member 302 and a device closure306 of an annuloplasty ring for percutaneous, trans-catheterannuloplasty repair according to certain embodiments. The illustratedbody member 302 may be similar to the internal body member 100 discussedabove in reference to FIGS. 1A, 1B, and 1C.

The body member 302 is laser cut into a desired shape. A cuttingpattern, such as cutting patter 200 shown in FIG. 2, may be used todefine regions of the body member 302 where the body member 302 may beflexible or rigid. In certain embodiments, anchors 304 are cut from thebody member 302. In other embodiment, the anchors 304 may be attached tobody member 302 by welding, adhesive, or other suitable fastening means.The anchors 304 are configured to attach the annuloplasty ring to theheart valve annulus.

The device closure 306 is used to secure two open ends of theannuloplasty ring to form a closed ring of the operable geometry. Incertain embodiments, a ring closure lock includes a female snap and amale snap. Examples of ring closure locks are provided in U.S. patentapplication Ser. No. 13/779,478.

A pivot 308 is attached to body member 302 and/or the device closure 306and is used to rotate the annuloplasty ring after deployment viacatheter within the heart to align the plane of the annuloplasty ring(in the annular operable geometry) with the plane of the heart valve.The pivot 308 may be manually coupled (e.g., using a pin, etc.), welded,or bonded using an adhesive. Upon exiting the catheter, the annuloplastyring may be rotated via the pivot 308 to allow the annuloplasty ring tobe properly positioned against the heart valve annulus. In someembodiments, the pivot 308 is used to rotate the annuloplasty ring suchthat the anchors 304 are propelled into the surrounding annular tissue.

FIGS. 4A, 4B, 4C, 4D, 4E, and 4F are perspective views of an anchordeployment system 400 for deploying anchors of an annuloplasty ring intoa heart valve annulus. The system 400 includes a body member 402 with aplurality of anchors 404, a plurality of retainer features 406, and aretaining ribbon 408. The body member 402 also includes the body members100, 300 discussed above in reference to FIGS. 1A, 1B, and 1C and FIG.3. The anchors 404 are heat treated to extend away from the body member402 so as to anchor the body member 402 into heart valve annulus tissue.In some embodiments, the anchors 404 curve away from the body member402. The anchors 404 may curve in the opposite direction from the bodymember 402. For example, if newly cut anchors curve to the right,heat-set anchors would curve to the left, similar to the anchors 104shown in FIG. 1B.

Referring again to FIGS. 4A, 4B, 4C, 4D, 4E, and 4F, certainannuloplasty ring embodiments include the retaining ribbon 408 disposedabout an outer circumference of the body member 402, or selectedportions thereof. The retaining ribbon 408 prevents the anchors 404 fromdeploying until the annuloplasty ring is properly positioned against theheart valve annulus. The retainer features 406 are disposed in pairs oneither side of each anchor 404 and are configured to hold the retainingribbon 408 against the surface body member 402. The plurality of anchors404 have superelastic properties allowing them to spring back into theirheat-set shape as described above. Additionally, the opposite-curvatureof the anchors causes the anchors 404 to spring into tissue with extraforce. Prior to deployment, stress is applied to anchors 404 causingthem to lie flush with the body member 402. The retaining ribbon 408 isinserted between the anchors 404 and the retainer features 406 therebyholding the anchors 404 flush with the body member 402. In someembodiments, when the body member 402 is configured in the operablegeometry and positioned around the annulus, the retaining ribbon 408 isretracted so that the anchors 404 deploy. When the retaining ribbon 408retracts past an anchor 404, the stress on the anchor 404 is releasedcausing the anchor 404 to self-deploy into the annulus tissue. In otherembodiments, the anchors 404 are deployed before the body member 402 isplaced in the operable geometry.

FIGS. 4A and 4B are views of an anchor deployment system 400 wherein theretaining ribbon 408 is disposed between the anchors 404 and theretainer features 406. FIG. 4B is an enlarged view of the anchordeployment system of FIG. 4A showing how the retaining ribbon 408 isdisposed between an anchor 404 and a pair of retainer features 406thereby preventing the anchor 404 from deploying.

FIGS. 4C and 4D are views of the anchor deployment system 400 when theretaining ribbon 408 is partially retracted past an anchor 404. In someembodiments, the strength and/or rigidity of the retaining ribbon 408 issufficient to prevent the anchor 404 from deploying until the retainingribbon 408 has retracted across the entire anchor 404. In otherembodiments, the strength and/or rigidity of the retaining ribbon 408 issufficient to prevent the anchor 404 from deploying until the retainingribbon 408 has retracted halfway across the anchor 404. In yet otherembodiments, the strength and/or rigidity of the retaining ribbon 408 isonly sufficient to prevent the anchor 404 from deploying until theretaining ribbon 408 has retracted past the first retainer feature 406of the pair of retainer features 406 surrounding the anchor 404. FIG. 4Dis an enlarged view of the anchor deployment system of FIG. 4C showinghow the retaining ribbon is partially retracted across an anchor 404.

FIGS. 4E and 4F are views of the anchor deployment system 400 when theretaining ribbon 408 is fully retracted past an anchor 404. When theforce applied to an anchor 404 by the retaining ribbon 408 becomesinsufficient, the anchor 404 self-propels into the annulus tissuethereby anchoring the annuloplasty ring into the heart valve annulus.FIG. 4F is an enlarged view of the anchor deployment system of FIG. 4Eshowing the retaining ribbon fully retracted past an anchor 404.

FIGS. 5A, 5B, 5C, and 5D are perspective views of an anchor deploymentsystem 500 for deploying anchors of an annuloplasty ring into a heartvalve annulus according to certain embodiments. The system 500 includesa body member 502 with a plurality of anchors 504, and an outer tube orretaining cover 506. In some embodiments, the retaining cover 506includes a plurality of deployment windows 508 through which theplurality of anchors 504 are deployed, each deployment window 508corresponding to an anchor 504. In yet other embodiments, the pluralityof anchors 504 are configured to puncture through the retaining cover506 during deployment. The body member 502 may be similar to the bodymember 100, 300, and 402 discussed above in reference to FIGS. 1A, 1B,and 1C, 3, and 4A, 4B, 4C, 4D, 4E, and 4F. The anchors 504 have beenheat treated to extend away from the annuloplasty ring 502 so as toanchor the annuloplasty ring 502 into heart valve annulus tissue.

Certain annuloplasty ring embodiments include an outer tube or retainingcover 506 disposed about the entire circumference of the annuloplastyring 502, or selected portions thereof. For example, in certainembodiments, the retaining cover 506 is disposed so as to enclose theanchors 504 and the expansion region(s), while leaving uncovered atleast portions of a closure mechanism (to permit snapping the ends ofthe annuloplasty ring together). The retaining cover 506 prevents theanchors 504 from deploying until the annuloplasty ring is properlypositioned against the heart valve annulus. The plurality of anchors 504have superelastic properties allowing them to spring back into theirheat-set shape as described above. The superelastic property of theanchors 504, combined with the opposite-curvature of the anchors, isused to self-propel the anchors 504 into the annulus of the heart valve.The opposite curvature of the anchors 504 causes them to spring intotissue with extra force. Prior to deployment, stress is applied toanchors 504 causing them to lie flush with the body member 502. The bodymember 502, including anchors 504, is inserted into the retaining cover506 thereby holding the anchors 504 flush with the body member 502 andpreventing their deployment. In some embodiments, when the annuloplastyring is configured in the operable geometry and positioned around theannulus, the body member 502 is rotated within the retaining cover 506.When the anchors 504 are rotated to the deployment windows 508, thestress on the anchors 504 is released, allowing the anchors 504 toself-deploy into the annulus tissue. In other embodiments, the anchors504 are deployed before the annuloplasty ring 502 is placed in theoperable geometry.

FIG. 5A is a perspective view of the retaining cover 506 including theplurality of deployment windows 508. The retaining cover 506 may includea biocompatible material such as Dacron®, woven velour, polyurethane,polytetrafluoroethylene (PTFE), heparin-coated fabric, or the like. Inother embodiments, the retaining cover 506 includes a biologicalmaterial such as bovine or equine pericardium, homograft, patient graft,or cell-seeded tissue.

FIG. 5B is a perspective view of the body member 502 after beinginserted into the retaining cover 506. In FIG. 5B, the body member 502is in the elongated configuration. After being deployed into the heartthrough a catheter, the body member 502 is placed into an annularoperable geometry. The retaining cover 506 is flexible and continues tosurround the annuloplasty ring 502 while in the operable geometry.

FIG. 5C is an enlarged perspective view of the anchor deployment system500. As seen in FIG. 5C, the tip 504 a of the anchor 504 is at thedeployment window 508, but the body member 502 may be rotated furtherbefore the anchor 504 deploys into the annular tissue. As the bodymember 502 rotates in the direction of arrow 510, the elastic force ofthe anchor 504 causes the tip 504A to protrude from the deploymentwindow 508. Further rotation in the direction of the arrow 510 causesmore of the anchor 504 to protrude beyond the retaining cover 506 as theanchor deploys.

FIG. 5D is an enlarged perspective view of the anchor deployment system500. As seen in FIG. 5D, the continued rotation of the body member 502causes the anchor 504 to deploy. Referring back to FIGS. 5A and 5B, inthe illustrated embodiment, the deployment windows 508 are aligned witheach other causing all the anchors 504 to simultaneously deploy as thebody member 502 rotates within the retaining cover 506. In otherembodiments, the deployment windows 508 may be disposed on the retainingcover 506 in an unaligned manner so that the anchors 504 deploy in adesired sequence. Where simultaneous deployment is not desired, thedeployment windows 508 may have oval, oblong, or rectangular shapes sothat continued rotation will not retract deployed anchors or displacethe annuloplasty ring 502 from its position around the heart valveannulus.

FIG. 6 is a perspective view of an annuloplasty ring 600 including ananchor deployment system according to certain embodiments. In someembodiments, the anchor system shown in FIG. 6 may be combined with theanchor deployment system 500 shown in FIG. 5. The annuloplasty ring 600includes a shape memory body member 602, a plurality of anchors 604, anouter tube 606, and a deployment wire 608. The deployment wire 608 isattached to the body member 602 and is used to selectively deploy theanchors 604. The plurality of anchors 604 are attached to the shapememory body member 602. In some embodiments, the anchors 604 are weldedto the shape memory body member 602. In other embodiments, the anchors604 are laser cut from the side of the shape memory body member 602 andthen heat-set to a curved, deployed configuration, similar to theanchors 104 discussed above in reference to FIGS. 1A, 1B, and 1C. Insome embodiments, the anchors 604 are curved when in the deployedconfiguration. The anchors 604 may curve away from the body member 602.In some embodiments, the anchors 604 curve in the opposite directionfrom the body member 602. The anchors 604 in other embodiments mayinclude other shapes, such as linear or helical deployed configurations.In certain embodiments, the anchors 604 include a shape memory material(e.g., Nitinol) that is heat set to a deployed configuration (e.g.,linear, helical, or curved). Artisans will recognize from the disclosureherein that combinations of barb designs and/or deployed configurationsmay also be used.

In some embodiments, the anchors 604 are superelastic such that applyingsufficient stress places the anchors 604 into an introductionconfiguration and releasing the stress allows the anchors 604 to resumetheir respective deployed configurations. In certain embodiments, theanchors 604 lay in-line with the body member 602 when in theintroduction configuration to facilitate insertion of the annuloplastyring 600 through a catheter. The body member 602, including the anchors604, is inserted into the outer tube 606 thereby holding the anchors 604flush with the body member 602 and preventing their deployment. In someembodiments, the body member 602 runs the full length of the outer tube606. In other embodiments, the body member 602 is segmented intomultiple segments. The outer tube 606 prevents the anchors 604 fromdeploying until properly positioned against the heart valve annulus. Insuch embodiments, the anchors 604 may be selectively deployed at adesired time (e.g., after the body member 602 is properly positionedagainst the annulus of the heart valve). The superelastic property ofthe anchors 604, combined with the opposite curvature of the anchors,causes the anchors 604 to spring into tissue with extra force.

When the annuloplasty ring 600 is configured in an operable geometry andpositioned around the annulus, the body member 602 is rotated within theouter tube 606 via the deployment wire 608, causing the anchors 604 todeploy. The deployment wire 608 passes inside the outer tube 606 andattaches to the body member 602. The deployment wire 608 is a torquewire capable of applying torque to the body member 602. To deploy theanchors, the deployment wire 608 is rotated in the direction of arrow612, which results in the body member 602 rotating in the direction ofarrow 614. As the body member 602 rotates, the anchors 604 deploythrough the outer tube 606.

In some embodiments, the outer tube 606 includes a plurality of anchordeployment windows 610 that allow the anchors 604 to pass through theouter tube 606. When the anchors 604 are rotated within the outer tube606 to the deployment windows 610, the stress on the anchors 604 isreleased allowing the anchors 604 to deploy. The superelastic propertyof the anchors 604, combined with the opposite curvature of the anchors,causes the anchors 604 to vigorously spring out of the deploymentwindows 610.

The outer tube 606 may include a biocompatible material such as Dacron®,woven velour, polyurethane, polytetrafluoroethylene (PTFE),heparin-coated fabric, or the like. In other embodiments, the outer tube606 includes a biological material such as bovine or equine pericardium,homograft, patient graft, or cell-seeded tissue.

FIG. 7A is a perspective view of an annuloplasty ring 700 includinganother anchor deployment system according to the present disclosure. Insome embodiments, the anchor system shown in FIG. 7 may be combined withthe anchor deployment system 500 shown in FIG. 5. The anchor deploymentsystem is used to deploy anchors of an annuloplasty ring 700, such asthose described in the present disclosure. The annuloplasty ring 700includes a shape memory body member 702, a plurality of anchors 704, anouter tube 706, and a deployment wire 708. The deployment wire 708 isattached to the body member 702 and is used to selectively deploy theanchors 704. The plurality of anchors 704 are attached to the shapememory body member 702. In some embodiments, the anchors 704 are weldedto the shape memory body member 702. In other embodiments, the anchors704 are laser cut from the side of the shape memory body member 702 andthen heat-set to a curved, deployed configuration, similar to theanchors 104 discussed above in reference to FIGS. 1A, 1B, and 1C. Insome embodiments, the anchors 704 are curved when in the deployedconfiguration. The anchors 704 may curve away from the body member 702.In some embodiments, the anchors 704 curve in the opposite directionfrom the body member 702. The anchors 704 in other embodiments mayinclude other shapes, such as linear or helical deployed configurations.In certain embodiments, the anchors 704 include a shape memory material(e.g., Nitinol) that is heat set to a deployed configuration (e.g.,linear, helical, or curved). Artisans will recognize from the disclosureherein that combinations of barb designs and/or deployed configurationsmay also be used.

In some embodiments, the anchors 704 are superelastic such that applyingsufficient stress places the anchors 704 into an introductionconfiguration and releasing the stress allows the anchors 704 to resumetheir respective deployed configurations. In certain embodiments, theanchors 704 lay in-line with the body member 702 when in theintroduction configuration to facilitate insertion of the body member702 through the catheter. The body member 702, including anchors 704, isinserted into the outer tube 706 thereby holding the anchors 704 flushwith the body member 702 and preventing their deployment. In someembodiments, the body member 702 runs the full length of the outer tube706. In other embodiments, the body member 702 is segmented intomultiple segments. The outer tube 706 prevents the anchors 704 fromdeploying until properly positioned against the heart valve annulus. Insuch embodiments, the anchors 704 may be selectively deployed at adesired time (e.g., after the annuloplasty ring is properly positionedagainst the annulus of the heart valve). The superelastic property ofthe anchors 704, combined with the opposite curvature of the anchors,causes the anchors 704 to spring into tissue with extra force.

When the annuloplasty ring 700 is configured in an operable geometry andpositioned around the annulus, the body member 702 is rotated within theouter tube 706 via the deployment wire 708, causing the anchors 704 todeploy. The deployment wire 708 passes inside the outer tube 706 and iscoupled to a rotation member (not shown). The rotation member transformslinear movement of the deployment wire 708 into rotational movement ofthe body member 702. To deploy the anchors 704, the deployment wire 708is pulled in the direction of arrow 712, which results in the bodymember 702 rotating in the direction of arrow 714. As the body member702 rotates, the anchors 704 deploy through the outer tube 706.

In some embodiments, the outer tube 706 includes a plurality of anchordeployment windows 710 that allow the anchors 704 to pass through theouter tube 706. When the anchors 704 are rotated within the outer tube706 to the deployment windows 710, the stress on the anchors 704 isreleased allowing the anchors 704 to deploy. The superelastic propertyof the anchors 704, combined with the opposite curvature of the anchors,causes the anchors 704 to vigorously spring out of the deploymentwindows 710.

The outer tube 706 may include a biocompatible material such as Dacron®,woven velour, polyurethane, polytetrafluoroethylene (PTFE),heparin-coated fabric, or the like. In other embodiments, the outer tube706 includes a biological material such as bovine or equine pericardium,homograft, patient graft, or cell-seeded tissue.

FIG. 7B is a perspective view of a rotation member 716 for use with theanchor deployment system 700 shown in FIG. 7A according to certainembodiments. The rotation member 716 includes one or more threadedgrooves 718 configured to apply torque to the body member 702. Therotation member 716 further includes a hole 720 through which a roundwire (such as deployment wire 708) may pass.

FIG. 7C is a perspective view of a rotation member 722 for use with theanchor deployment system 700 shown in FIG. 7A according to certainembodiments. The rotation member 722 includes one or more threadedgrooves 718 configured to apply torque to the body member 702. Therotation member 722 further includes a hole 724 through which a flatwire or ribbon (such as deployment wire 708) may pass.

FIG. 7D is an enlarged perspective view of the annuloplasty ringincluding the anchor deployment system shown in FIG. 7A. In someembodiments, the body member 702 includes one or more inner tabs 728configured to engage the threaded grooves 718 of the rotation member 716shown in FIG. 7B (or the rotation member 722 shown in FIG. 7C). As thedeployment wire 708 moves linearly (e.g., is pushed or pulled by auser), the rotation member 716 applies torque to the body member 702 viathe groove 718 moving along the inner tabs 728. The rotation of bodymember 702 causes anchors 704 to deploy.

FIG. 7E is a cross-sectional, perspective view of the annuloplasty ringincluding the anchor deployment system shown in FIG. 7A. As shown, thedeployment wire 708 passed through rotation member 716. Rotation member716 is located inside body member 702 and the threaded grooves 718engage the inner tabs 728 to cause body member 702 to rotate withinouter tube 706. When the rotation of body member 702 causes the anchors704 to reach the deployment windows 710, the anchors 704 deploy throughthe outer tube 706.

Example Ring Embodiments with Separately Deployed Anchors

FIG. 8A is top view of an annuloplasty ring 800 in an operative geometryaccording to certain embodiments. The annuloplasty ring 800 illustratedin FIG. 8A is in an annular (D-shaped) operable geometry in a contractedstate. The annuloplasty ring 800 is configured to enable percutaneous,transcatheter annuloplasty repair of a heart valve. The annuloplastyring 800 may be fastened, percutaneously, to the annulus of the heartvalve while in the expanded state and then reduced to the contractedstate to decrease an A-P distance of the target valve and therebyimprove leaflet coaptation of the target valve and reduce regurgitationthrough the target valve.

The annuloplasty ring 800 includes a body member 802 having a pluralityof anchors 804, a plurality of anchor regions 806 a, 806 b, 806 c(collectively 806), a plurality of expansion regions 808 a, 808 b(collectively 808), a plurality of anchor windows 810, a ring closurelock 812, and a pivot 814. In some embodiments, the anchors 804 may beseparately deployed through the anchor windows 810. In FIG. 8A the bodymember 802, including the plurality of regions 806, 808, is arranged ina “D-shape” in the operable geometry. The D-shaped annuloplasty ring 800has a certain geometrical ratio that is in conformance (or approximateconformance) with the anatomical geometry of the human mitral valveannulus. For example, in certain embodiments the ratio of the A-Pdistance to the commissure-commissure (C-C) distance of the annuloplastyring 800 when implanted (i.e., in the contracted state) is in a rangebetween about 0.60 and about 0.70. In one embodiment, the implantedratio of the A-P distance to the C-C distance is about 0.62.

Although the illustrated embodiment of an annuloplasty ring 800 of FIG.8A is a D-shaped operable geometry, artisans will recognize from thedisclosure herein that other annular-shaped operable geometries may alsobe used. For example, circular, oval, or C-shaped operable geometriesmay be used.

The body member 802 may be cut from, for example, a tube to form theplurality of regions 806, 808. The cuts may define a shape and/orcharacteristics of the body member 802. For example, the laser cuts maydefine the anchor regions 806, expansion regions 808, and/or the anchorwindows 810. The laser cuts may also define how the plurality of regions806, 808 interacts.

In certain embodiments, the body member 802 may include a shape memory(e.g., Nitinol) hypotube into which a plurality of cuts and/or segmentsmay be laser cut to define a size, shape, and/or characteristics of theplurality of regions 806, 808. The shape memory body member 802 may beheat set to a “memorized” annular shape (e.g., the D-shaped operablegeometry). The shape memory body member 802 may be superelastic suchthat applying sufficient stress may place the annuloplasty ring 800 intothe elongate insertion geometry and releasing the stress allows theannuloplasty ring 800 to resume the D-shaped operable geometry.

In addition to the operable geometry shown in FIG. 8A the annuloplastyring 800 is transitionable from an elongate insertion geometry to theannular operable geometry shown in FIG. 8A. The elongate insertiongeometry allows the annuloplasty ring 800 to be inserted into and passedthrough a catheter for percutaneous passage of the annuloplasty ring 800into the heart of a patient. A transition from an elongate insertiongeometry to an annular operable geometry is illustrated in FIGS. 16A,16B, 16C, and 16D, and discussed below with reference to the same.

The anchors 804 are configured to secure the annuloplasty ring 800 tothe annulus of the heart valve. In certain embodiments, the anchors 804are sufficient such that additional suturing of the annuloplasty ring800 to the valve annulus is not needed. In FIG. 8A the anchors 804 arewithin the body member 802 in an introduction configuration. The anchors804 may be later deployed, as discussed below with reference to FIGS.9A, 9B, 9C, 9D, and 9E and FIGS. 10A, 10B, 10C, and 10D. The anchors 804may be selected from a plurality of shapes, such as curved, linear, orhelical deployed configurations. In certain embodiments, the anchors 804include a shape memory material (e.g., Nitinol) that is heat set to adeployed configuration (e.g., curved configuration, linearconfiguration, or helical configuration). Artisans will recognize fromthe disclosure herein that combinations of different deployed anchorconfigurations may also be used.

In some embodiments, the anchors 804 are in the same plane as theannuloplasty ring. In other embodiments, the anchors 804 deploy at anangle to the plane of the annuloplasty ring, such as 10°, 45°, or even90°.

In some embodiments, there are two or more anchor sections in theannuloplasty ring 800. The anchors 804 are integral to each anchorsection. Each anchor section may include two or more anchors 804.Additionally, multiple anchor sections may be placed in parallel witheach other to affect a more secure attachment of the ring to the nativeannulus.

The anchors 804 are superelastic such that applying sufficient stressplaces the anchors 804 into an introduction configuration and releasingthe stress allows the anchors 804 to resume their respective deployedconfigurations. In certain embodiments, the anchors 804 are retractedinside the body member 802 of the annuloplasty ring 800 in theintroduction configuration during insertion of the annuloplasty ring 800through the catheter. In such embodiments, the anchors 804 may beselectively deployed at a desired time (e.g., after the annuloplastyring 800 is properly positioned against, or in abutment with, theannulus of the heart valve). In certain embodiments, the superelasticproperty of the anchors 804 is used to self-propel the anchors 804 intothe annulus of the heart valve. The superelastic property of the anchors804, combined with the curvature of the anchors, causes the anchors 804to spring into tissue with extra force. The anchors 804 may beconfigured to be deployed from within the body member 802 through anchorwindows 810.

The ring closure lock 812 is used to secure two open ends of theannuloplasty ring 800 to form a closed ring of the operable geometry. Incertain embodiments, the ring closure lock 812 includes a female snapand a male snap. Examples of ring closure locks are provided in U.S.patent application Ser. No. 13/779,478.

The pivot 814 is used to automatically rotate the annuloplasty ring 800after it exits the catheter within the heart to align the plane of theannuloplasty ring 800 (in the annular operable geometry) with the planeof the heart valve. The annuloplasty ring 800 is pushed from thecatheter in a direction that is substantially perpendicular to the planeof the heart valve (e.g., parallel to the general direction of bloodflow through the valve). Upon exiting the catheter, the annuloplastyring 800 is rotated at or about the pivot 814 to allow properpositioning of the annuloplasty ring 800 against the annulus.

FIG. 8B is a schematic diagram illustrating a cutting pattern 850 usedfor laser processing a hypotube to form the body member 802 of theannuloplasty ring 800 shown in FIG. 8A. The cutting pattern 850corresponds to the entire body member 802 as if the body member 802 werecut along a longitudinal axis and unrolled. The cutting pattern 850enables cutting the hypotube to form the plurality of anchor regions 806and expansion regions 808. The cutting pattern 850 shown in FIG. 8Bdefines the configuration of the plurality of regions 806, 808 and howthe regions 806, 808 interact with adjacent regions as the body member802 transitions from the elongate insertion geometry to the annularoperable geometry.

The cutting pattern 850 also enables cutting the body member 802 to formanchor windows 810 through which the plurality of anchors 804 aredeployed. The cutting pattern 850 may also enable cutting the bodymember 802 to form one or more through holes 816, 818 at each end toallow one or more pins (not shown) to couple male and/or femalecomponents of the ring closure lock 812 to respective ends of the bodymember 802.

In certain embodiments, deployment of the anchors is accomplished usinginternal anchor members that are selectively movable within the bodymember of an annuloplasty ring. For example, FIGS. 9A, 9B, 9C, 9D, and9E are simplified views of an internal anchor ribbon 900 and an internalanchor ribbon 902, each anchor ribbon including a plurality of anchors904 a, 904 b (referred to collectively as anchors 904). The anchors 904are integral to each anchor ribbon 900, 902. Each anchor ribbon 900, 902includes two or more anchors 904. The anchors 904 may be affixed (e.g.,laser welded) to the internal anchor ribbons 900, 902 or directly cutinto the internal anchor ribbons 900, 902 (as discussed with respect toFIGS. 9A, 9B, and 9C). The anchors 904 may be similar to anchor 604discussed above in reference to FIG. 8A. For example, the anchors 904may be superelastic such that applying sufficient stress places theanchors 904 into an introduction configuration and releasing the stressallows the anchors 904 to resume their respective deployedconfigurations. The anchors 904 may be selectively deployed at a desiredtime (e.g., after the annuloplasty ring is properly positioned againstthe annulus of the heart valve). In certain embodiments, thesuperelastic property of the anchors 904 is used to self-propel theanchors 904 into the annulus of the heart valve. The superelasticproperty of the anchors 904, combined with the curvature of the anchors904, causes the anchors 904 to spring into tissue with extra force.

In some embodiments, the anchors 904 are in the same plane as the anchorribbons 900, 902. In other embodiments, the anchors deploy at an angleto the plane of the anchor ribbons 900, 902, such as 10° or 45°.Additionally, as shown in FIG. 9C, multiple anchor ribbons may be placedin parallel with each other to affect a more secure attachment of thering to the native annulus.

The internal anchor ribbons 900, 902 may be slid (e.g., using wires orsutures accessible through the catheter) within the body member of theannuloplasty ring. To reduce friction between the internal anchorribbons 900, 902 and the body member, certain embodiments include aninternal glide ribbon 910. The internal glide ribbon 910 may include alow-friction material (e.g., as a coating or covering) such as PTFE orother polymer.

FIG. 9A is a schematic diagram illustrating a top view of the anchors904 cut into the internal anchor ribbons 900, 902 shown in the elongateinsertion geometry according to one embodiment. In this example, a laseris used to cut the anchors 904 along a first side 912, a second side 914(e.g., in a pointed or tip shape), and a third side 916, while leaving afourth side 918 of the anchor 904 uncut and attached to the internalanchor ribbons 900, 902. After cutting, the anchors 904 are heat set tothe desired memorized shape for the deployed configuration. For example,FIG. 9B is a schematic diagram illustrating a side view of the internalanchor ribbons 900, 902 in the elongate insertion geometry and theanchors 904 in a deployed configuration according to one embodiment. Theamount of curvature in the deployed configuration of the anchors 904 maydepend on the particular application. In the example shown in FIG. 9B,the anchors 904 has a “wave” structure. Additionally, internal anchorribbons 900, 902 are arranged so that the anchors 904 a of internalanchor ribbon 900 point in the opposite direction from the anchors 904 bof internal anchor ribbon 902. When deployed, the opposing anchors 904a, 904 b provide improved anchoring when compared to anchors that allpoint in the same direction. FIG. 9C is a schematic diagram showing theinternal anchor ribbons 900, 902 arranged side by side. When arrangedside by side, the anchors 904 overlap, thereby providing improvedanchoring. FIG. 9D is a schematic diagram illustrating a top view of theinternal glide ribbon 910, and FIG. 9E is a schematic diagramillustrating a side view of the internal glide ribbon 910, in theelongate insertion geometry according to one embodiment.

In one embodiment, the anchor ribbons 900, 902 include a superelasticshape memory material (e.g., Nitinol) that is heat set to the samememorized annular shape as the body member 802 (shown in FIG. 8A asD-shaped). In addition, or in other embodiments, the internal glideribbon 910 includes a superelastic shape memory material (e.g., Nitinol)that is heat set to the same memorized annular shape as the body member802 (shown in FIG. 8A as D-shaped). Thus, certain embodiments includefour D-shaped superelastic members (the body member 802, the internalanchor ribbons 900, 902, and the internal glide ribbon 910), whichcooperate to shape and increase the rigidity of the ring 600.

FIGS. 10A, 10B, and 100 are simplified schematics illustratingcross-section side views of an annuloplasty ring 1000 before (FIG. 10A),partway through (FIG. 10B) and after (FIG. 10C) deployment of theanchors 904 shown in FIG. 9C according to one embodiment. Artisans willrecognize from the disclosure herein that the anchors 904 are generallydeployed when the ring 1000 is in the annular operable geometry. Thering 1000 may be similar to the annuloplasty ring 800 discussed above inreference to FIG. 8A.

The illustrated ring 1000 includes an outer tube 1002 (e.g., the bodymember 802 shown in FIG. 8A) including a plurality of anchor deploymentwindows 1010. During the manufacturing of the ring 1000 and before thering 1000 is loaded into the catheter, the internal anchor ribbons 900,902 and the internal glide ribbon 910 are inserted into the outer tube1002 in a position where the anchors 904 are prevented from exitingthrough the windows 1010. As shown in FIG. 10A, inserting the internalanchor ribbons 900, 902 into the outer tube 1002 prevents the anchors904 from assuming their fully curved deployed configuration. In theillustrated embodiment, each anchor 904 a of anchor ribbon 900 share ananchor deployment window 1010 with an anchor 904 b of anchor ribbon 902.In other embodiments, every anchor 904 a, 904 b has its own anchordeployment window 1010.

For deploying the anchors 904, the internal anchor ribbons 900, 902 mayinclude (or may be attached to) a hook or loop 1014 for engaging a wireor suture 1016 that may be pulled by a user through the catheter. As theanchors 904 a of the internal anchor ribbon 900 point in the oppositedirection from the anchors 904 b of the internal anchor ribbon 902, theanchor ribbon 900 is pulled in the direction of arrow 1018 while theanchor ribbon 902 is pulled in the opposite direction (e.g., in thedirection of arrow 1020). By pulling the anchor ribbons 900, 902 thetips of each anchor 904 move to a corresponding window 1010. In certainembodiments, the anchors 904 and windows 1010 are arranged such that thetip of each anchor 904 reaches its respective window 1010 atsubstantially the same time as the other anchors reach their windows. Asshown in FIG. 10B, once the tips of the anchors 904 a of the anchorribbon 900 reach the respective windows 1010, the superelasticity of theanchors 904 a propels the internal anchor ribbon 900 in the oppositedirection (shown by arrow 1020) as the anchors 904 a spring out throughthe windows 1010 (as indicated by arrow 1022) to resume their curvedconfigurations, thereby driving the anchors 904 a into surroundingtissue (e.g., the heart valve annulus). As shown in FIG. 10C, once thetips of the anchors 904 b of the anchor ribbon 902 reach the respectivewindows 1010, the superelasticity of the anchors 904 b propels theinternal anchor ribbon 902 in the opposite direction (shown by arrow1018) as the anchors 904 spring out the windows 1010 (as indicated byarrow 1024) to resume their curved configurations, thereby driving theanchors 904 b into surrounding tissue (e.g., the heart valve annulus).Thus, the superelasticity of the anchors 904 allows the anchors 904 tobe self-propelled into the tissue adjacent or proximate to the ring1000. While the sequence of FIGS. 10A, 10B, and 100 shows the anchorribbon 900 deploying before the anchor ribbon 902, artisans willrecognize that the anchor ribbon 902 may be deployed first, or theanchor ribbons 900, 902 may be deployed simultaneously.

FIG. 10D is a perspective view of a portion of the annuloplasty ring1000 shown in FIGS. 10A, 10B, and 10C with a pair of deployed anchors904 according to one embodiment. The outer tube 802 may include thewindows 810 (one window shown in FIG. 10D) described above andschematically represented in FIGS. 10A, 10B, and 100. In certainembodiments, the deployed anchors 904 form an angle with a plane of thering 1000 to provide the anchors 904 with improved access to the valveannulus when the ring is positioned against the valve annulus. Duringanchor deployment, the plane of the ring 1000 is substantially parallelto the plane of the valve annulus.

In certain embodiments, deployment of the anchors is accomplished usinga plurality of internal anchor members that are independently deployablewithin the body member of an annuloplasty ring. For example, FIGS. 11A,11B, 11C, and 11D are perspective views of an annuloplasty ring 1100with separately deployable anchor members according to certainembodiments. The annuloplasty ring 1100 may be similar to annuloplastyrings 800, 1000 discussed above in reference to FIGS. 8A, and 10A, 10B,10C, and 10D. The annuloplasty ring 1100 includes an outer tube or bodymember 1102, a plurality of anterior anchors 1104 a, a plurality offirst posterior anchors 1104 b, a plurality of second posterior anchors1104 c, a plurality of anterior anchor windows 1106 a, a plurality offirst posterior anchor windows 1106 b, a plurality of second posterioranchor windows 1106 c, an anterior anchor ribbon 1110, a first posterioranchor ribbon 1112, and a second posterior anchor ribbon 1114, eachanchor ribbon including a plurality of anchors 1104. The anterioranchors 1104 a, first posterior anchors 1104 b, and second posterioranchors 1104 c (collectively referred to as anchors 1104) are integralto their respective anchor ribbons 1110, 1112, 1114. The anchors 1104may be affixed (e.g., laser welded) to the anchor ribbons 1110, 1112,1114, respectively, or directly cut into the anchor ribbons 1110, 1112,1114. Each of the anchor ribbons 1110, 1112, 1114 includes two or moreanchors 1104. The anchors 1104 may be similar to anchors 804 discussedabove in reference to FIG. 8A. For example, the anchors 1104 may besuperelastic such that applying sufficient stress places the anchors1104 into an introduction configuration and releasing the stress allowsthe anchors 1104 to resume their respective deployed configurations. Theanchors 1104 may be selectively deployed at a desired time (e.g., afterthe annuloplasty ring 1100 is properly positioned against the annulus ofthe heart valve). In certain embodiments, the superelastic property ofthe anchors 1104 is used to self-propel the anchors 1104 into theannulus of the heart valve. The superelastic property of the anchors1104, combined with the curvature of the anchors 1104 causes the anchors1104 to spring into tissue with extra force. The anterior anchor windows1106 a, first posterior anchor windows 1106 b, and second posterioranchor windows 1106 c (collectively referred to as anchor windows 1106)allow the anchors 1104 to pass through the body member 1102 into theannular tissue.

In some embodiments, the anchors 1104 are in the same plane as theanchor ribbons 1110, 1112, 1114. In other embodiments, the anchorsdeploy at an angle to the plane of the anchor ribbons 1110, 1112, 1114,such as 10° or 45°. Additionally, multiple anchor sections may be placedin parallel with each other to affect a more secure attachment of thering to the native annulus.

FIG. 11A shows the ring 1100 in the operative configuration with theanchors 1104 in the introduction configuration. FIG. 11D shows the ring1100 in the operative configuration with the anchors 1104 in thedeployed configuration. Artisans will recognize from the disclosureherein that the anchors 1104 are generally deployed when the ring 1100is in the annular operable geometry and in proximity to the heart valveannulus. The amount of curvature in the deployed configuration of theanchors 1104 may depend on the particular application. In the exampleshown in FIGS. 11B, 11C, and 11D, the anchors 1104 have a curledstructure such that the prong or tip points at the anchor ribbons 1110,1112, 1114. When deployed, the curled anchors provide secure anchoringin the annular tissue.

FIG. 11B shows the anterior anchor ribbon 1110 with the anterior anchors1104 a arranged in the deployed, operative configuration. FIG. 11C showsthe first posterior anchor ribbon 1112 and the second posterior anchorribbon 1114 with the first posterior anchors 1104 b and the secondposterior anchors 1104 c arranged in the deployed, operativeconfiguration. The anchor ribbons 1110, 1112, 1114 may be slid (e.g.,using wires or sutures accessible through the catheter) within the bodymember 1102 of the annuloplasty ring 1100. To reduce friction betweenthe anchor ribbons 1110, 1112, 1114 and the body member, certainembodiments include an internal glide ribbon (not shown) that mayincludes a low-friction material (e.g., as a coating or covering) suchas PTFE or other polymer. The anchor ribbons 1110, 1112, 1114 include asuperelastic shape memory material (e.g., Nitinol) that is heat set tothe same memorized annular shape as the body member 1102 (shown in FIG.11D as D-shaped). In certain embodiments, the internal glide ribbonincludes a superelastic shape memory material (e.g., Nitinol) that isheat set to the same memorized annular shape as the body member 1102.Thus, certain embodiments include five D-shaped superelastic members(the body member 1102, the anchor ribbons 1110, 1112, 1114, and theinternal glide ribbon), which cooperate to increase the rigidity of thering 1100.

The body member 1102 includes a plurality of anchor deployment windows1106. During the manufacturing of the ring 1100, and before the ring1100 is loaded into the catheter, the anchor ribbons 1110, 1112, 1114are inserted into the body member 1102 in a position where the anchors1104 are prevented from exiting through the anchor windows 1106. This isreferred to as the introduction configuration. As shown in FIG. 11A, thebody member 1102 prevents the anchors 1104 from assuming their fullycurved deployed configuration.

For deploying the anchors 1104, the anchor ribbons 1110, 1112, 1114 mayinclude (or may be attached to) a hook or loop (not shown) for engaginga wire or suture that may be pulled by a user through the catheter.Pulling the anchor ribbons 1110, 1112, 1114 moves the tips of eachanchor 1104 to a deployment window 1106. In certain embodiments, theanchors 1104 and windows 1106 are arranged such that the tip of eachanchor 1104 on an anchor ribbon (e.g., anterior anchor ribbon 1110)reaches its respective window 1106 at substantially the same time as theother anchors 1104 on the anchor ribbon reach their window 1106. Oncethe tips of the anchors 1104 of an anchor ribbon reach the respectivewindows 1106, the superelasticity of the anchors 1104 springs them outthrough the windows 1106 to resume their curved configurations, therebydriving the anchors 1104 into surrounding tissue (e.g., the heart valveannulus). Thus, the superelasticity of the anchors 1104 allows theanchors 1104 to be self-propelled into the tissue adjacent, orproximate, to the ring 1100.

As seen in FIGS. 12A, 12B, 12C, and 12D, the anchor ribbons may bedeployed in an independent manner because each anchor ribbon 1110, 1112,or 1114 is independent of the others. Accordingly, the anchors 1104 maybe selectively deployed from different locations of the annuloplastyring 1100 at different times.

FIG. 12A shows the annuloplasty ring 1100 in the operative configurationwith the anchors 1104 in the introduction configuration. Theannuloplasty ring 1100 is maneuvered into position near the heart valveannulus before the anchors 1104 are deployed.

FIG. 12B shows the annuloplasty ring 1100 with the anterior anchors 1104a deployed. To transition from FIG. 12A to FIG. 12B, the anterior anchorribbon 1110 is pulled within the body member 1102 until the anterioranchors 1104 a reach the anterior deployment windows 1106 a. Uponreaching the anterior deployment windows 1106 a, the anterior anchors1104 a self-propel into the deployment configuration.

FIG. 12C shows the annuloplasty ring 1100 with the anterior anchors 1104a and the first posterior anchors 1104 b deployed. To transition fromFIG. 12B to FIG. 12C, the first posterior anchor ribbon 1112 is pulledwithin the body member 1102 until the first posterior anchors 1104 breach the first posterior deployment windows 1106 b. Upon reaching thefirst posterior deployment windows 1106 b, the first posterior anchors1104 b self-propel into the deployment configuration.

FIG. 12D shows the annuloplasty ring 1100 with the anterior anchors 1104a, the first posterior anchors 1104 b and the second posterior anchors1104 c deployed. To transition from FIG. 12C to FIG. 12D, the secondposterior anchor ribbon 1114 is pulled within the body member 1102 untilthe second posterior anchors 1104 c reach the second posteriordeployment windows 1106 c. Upon reaching the second posterior deploymentwindows 1106 c, the second posterior anchors 1104 c self-propel into thedeployment configuration.

Although the sequence of FIGS. 12B, 12C, and 12D shows the anterioranchors 1104 a deploying first, then the first posterior anchors 1104 b,and finally the second posterior anchors 1140 c, artisans will recognizethat the anchors 1104 a, 1104 b, 1104 c may be deployed in any order,including simultaneously.

Example Anchor Shapes and Designs

FIG. 13 is a view of various anchor shapes that may be used with thedisclosed trans-catheter annuloplasty rings. Anchor shapes 1300, 1320,and 1330 have curved geometries and may be formed from superelasticmaterial, such as Nitinol, so that they self-propel into annulus tissue.The variations in curvature and shape allow for the anchors to deployinto the annular tissue at differing depths. Anchor shape 1310 has a“wavy” geometry. The wave shape gives better grip into the tissue incertain environments. Anchor shape 1340 has a straight geometry and maybe propelled into annular tissue through application of mechanical force(e.g., by inflating a balloon behind anchor 1340 or in the center of theannuloplasty ring). Artisans will recognize from the disclosure hereinthat combinations of barb designs and/or deployed configurations mayalso be used. In some embodiments, all of the anchors of an annuloplastyrings are of the same shape. In other embodiments, an annuloplasty ringmay employ a plurality of anchor shapes. For example, one anchor shapemay be used to anchor the annuloplasty ring into the anterior portion ofthe heart valve annulus while a different anchor shape may be used toanchor the annuloplasty ring into the posterior portion of the heartvalve annulus. The selected anchor shape or geometry may depend on theparticular application.

FIG. 14 is a view of various anchor designs that may be used with thedisclosed trans-catheter annuloplasty rings. The different designs maybe employed to give an anchor greater flexibility or strength, and/or toenhance anchoring within the heart tissue. Controlling the strength ofthe anchors provides improved tissue penetration by using the strengthof the anchors as a driving mechanism. Controlling the elasticity of theanchors allows the anchors to recover from the configuration inside thecatheter, when the anchors are in their original cut patter, to theirfinal (deployed) configuration after heat treatment. Anchor design 1400employs ovoid or rounded-rectangular cutouts along the length of theanchor to provide the anchor with high strength and low elasticity.Anchor design 1410 employs wave cutouts along the length of the anchorto provide the anchor with medium strength and high elasticity (e.g., soas to better act like a spring). Anchor design 1420 employs three offsetlines of ovoid or rounded-rectangular cutouts along the length of theanchor to provide the anchor with medium strength and high elasticity(e.g., so as to better act like a spring). Anchor design 1430 employsovoid or rounded-rectangular cutouts along the length of the anchor. Thecutouts of anchor design 1430 are oriented perpendicularly to the lengthof the anchor (and to the cutouts of anchor design 1400). Anchor design1440 employs a single ovoid or rounded-rectangular cutout along thelength of the anchor to provide medium strength and medium elasticity tothe anchor. Anchor design 1450 employs two ovoid or rounded-rectangularcutouts along the length of the anchor. Artisans will recognize from thedisclosure herein that combinations of barb designs and/or deployedconfigurations may also be used. The selected anchor design may dependon the particular application.

Example Deployment Embodiments

As discussed above, the annuloplasty ring embodiments disclosed hereinare configured for percutaneous transcatheter delivery and fixation toheart valves. The annuloplasty rings may be delivered through a catheterto the mitral valve, for example, using a trans-septal approach, aretrograde approach, or a trans-apical approach. For example, FIG. 15Ais a schematic diagram illustrating a trans-septal approach forendovascular delivery of an annuloplasty ring (not shown) to the mitralvalve 1510 of a heart 1500 according to one embodiment. For illustrativepurposes, a partial cross-section of the heart 1500 is illustrated toshow the right atrium RA, right ventricle RV, left atrium LA, and leftventricle LV. For clarity, certain features (e.g., papillary muscles andchordae tendineae) are not shown. In the trans-septal approach shown inFIG. 15A, the left atrium LA is approached by advancement of a catheter1512 through the inferior vena cava 1514, into the right atrium RA,across the interatrial septum 1516, and into the left atrium LA. Theannuloplasty ring may then be delivered through the catheter 1512 intothe atrium and anchored to the annulus of the mitral valve 1510.

As shown in FIG. 15A, the catheter 1512 is delivered percutaneously intothe heart 1500. A guiding sheath (not shown) may be placed in thevasculature system of the patient and used to guide the catheter 1512and its distal end 1518 to a desired deployment site. In someembodiments, a guide wire (not shown) is used to gain access through thesuperior or inferior vena cava 1514, for example, through groin accessfor delivery through the inferior vena cava 1514. The guiding sheath maybe advanced over the guide wire and into the inferior vena cava 1514shown in FIG. 15A. The catheter 1512 may be passed through the rightatrium RA and toward the interatrial septum 1516. Once the distal end1518 of the catheter 1512 is positioned proximate to the interatrialseptum 1516, a needle or piercing member (not shown) is advanced throughthe catheter 1512 and used to puncture the fossa ovalis or other portionof the interatrial septum 1516. In some embodiments, the catheter 1512is dimensioned and sized to pass through the fossa ovalis withoutrequiring a puncturing device. That is, the catheter 1512 may passthrough the natural anatomical structure of the fossa ovalis into theleft atrium LA.

Similarly, any chamber (LV, RV, LA, RA) of the heart 1500 may beapproached through the inferior vena cava 1514. For example, the rightventricle RV may be approached through the inferior vena cava 1514, intothe right atrium RA, and through the tricuspid valve 1520. A variety ofother endovascular approaches may also be used.

FIG. 15B is a schematic diagram illustrating an example retrogradeapproach of an annuloplasty ring (not shown) to the mitral valve 1510 ofa heart 1500 according to another embodiment. In FIG. 15B, a femoralapproach is shown wherein the delivery catheter 1512 is advanced throughthe aorta 1522 and the aortic valve 1524. Typically, the catheter 1512is advanced through a sheath positioned within the femoral artery (notshown). Under fluoroscopy or other methods of guidance, the distal endof the catheter 1512 is guided within the left ventricle LV and turned(e.g., as shown with a “U-turn” 1526) within the left ventricle LV so asto pass through the leaflets of the mitral valve 1510 and into the leftatrium LA. After verification of the appropriate positioning of thecatheter 1512, a guide wire (not shown) may be inserted through thecatheter 1512 into the left atrium LA, which may then be used to guideone or more other catheters into the left atrium LA for delivering andanchoring the annuloplasty ring to the annulus of the mitral valve 1510.

FIG. 15C is a schematic diagram illustrating an example trans-apicalapproach of an annuloplasty ring (not shown) to the mitral valve 1510 ofa heart 1500 according to another embodiment. In this example, thecatheter 1512 is shown passing through the apex 1530 of the heart 1500,through the left ventricle LV, through the leaflets of the mitral valve1510, and into the left atrium. The annuloplasty ring may be deliveredthrough the catheter 1512 into the left atrium LA and anchored to theannulus of the mitral valve 1510. In one embodiment, a needle or trocarmay be used to puncture through the apex 1530 to create a small openingthrough which a guide wire (not shown) can be inserted through the leftventricle LV into the left atrium LA. Then, the guide wire may be usedto guide successively larger and stiffer catheters so as to graduallyincrease the size of the opening in the apex 1530 of the heart 1500.

In some embodiments, an annuloplasty ring will comprise a pivot used torotate the annuloplasty ring after it exits the catheter within theheart to align the plane of the annuloplasty ring (in the annularoperable geometry) with the plane of the heart valve. The annuloplastyring is pushed from the catheter in a direction that is substantiallyperpendicular to the plane of the heart valve (e.g., parallel to thedirection of blood flow). Upon exiting the catheter, annuloplasty ringmay be rotated via the pivot to allow the annuloplasty ring to beproperly positioned against the annulus. In some embodiments, theannuloplasty ring is expanded at one or more expansion region(s) andpressed against the valve annulus (e.g., using a balloon) beforedeploying the anchors. The act of deploying the anchors drives theanchors into the tissue. Fluoroscopy, ultrasound, and/or other imagingtechniques may be used to assist in proper positioning of theannuloplasty ring against the heart valve annulus.

Prior to deploying the anchors, the annuloplasty ring may be adjusted inthe anterior-posterior (A-P) direction to for proper placement. Examplesof an annuloplasty ring adjustable in the A-P direction are provided inU.S. patent application Ser. No. 13/779,478. After the anchors aredeployed into the annulus tissue, the annuloplasty ring is allowed tocontract thereby reducing the heart valve annulus dimensions andreducing regurgitation through the heart valve.

FIGS. 16A, 16B, 16C, and 16D are schematic diagrams illustratingtranscatheter delivery of an annuloplasty ring 1602 from a deliverysystem 1600 according to certain embodiments. FIG. 16A illustrates aperspective view of a distal end 1610 of the delivery system 1600. FIG.16A is a perspective view of the annuloplasty ring 1602 in the elongateinsertion geometry and partially deployed from the distal end 1610 of adelivery catheter 1614 in a first deployment stage. In the first stage,the annuloplasty ring 1602 may be still substantially in the elongateinsertion geometry. As shown in FIG. 16A, a first suture 1619 forsnapping together the ends of the annuloplasty ring 1602 passes througha male snap 1612 of a ring closure lock 1650 (shown in FIG. 16C).

FIG. 16B is a perspective view of the annuloplasty ring 1602 in a secondstage of partial deployment from the delivery catheter 1614. In thesecond stage, the portion of the annuloplasty ring 1602 that has exitedthe delivery catheter 1614 has begun to transition (due to the shapememory materials used in the annuloplasty ring 1602) from the elongateinsertion geometry to the annular operable geometry.

FIG. 16C is a perspective view of the annuloplasty ring 1602 in a thirdstage of deployment in which a ring shuttle 1616 of the delivery system1600 has substantially pushed the annuloplasty ring 1602 out of thedelivery catheter 1614, but the plane of the annuloplasty ring 1602 isstill aligned with (e.g., approximately parallel to) the longitudinalaxis of the delivery catheter 1614. In FIG. 16C, the annuloplasty ring1602 may be in a configuration, for example, immediately before a ringdeployment wire 1623 cooperates with the pivot 1608 to rotate theannuloplasty ring 1602 (see FIG. 16D). In the configuration shown inFIG. 16C, the distal end of the ring deployment wire 1623 includes abend or hook 1632 as it passes through a hole in the pivot 1608. Thering deployment wire 1623 includes a superelastic shape memory material(e.g., Nitinol), and bending the distal end of the ring deployment wire1623 into the hook 1632 shape spring loads the annuloplasty ring 1602within the outer jacket delivery catheter 1614 such that theannuloplasty ring 1602 automatically rotates about the pivot 1608 uponexiting the outer jacket delivery catheter 1614. At this third stage ofdeployment, the hook 1632 shape formed in the superelastic ringdeployment wire 1623 is ready to unload (return to a heat-set memorizedstraight configuration) as soon as the delivery catheter 1614 no longerprevents it from doing so. The suture 1619 may be utilized to drawtogether the male components 1652 and female components 1654 of a ringclosure lock 1650.

FIG. 16D is a perspective view of the annuloplasty ring 1602 in a fourthstage of deployment in which the plane of the annuloplasty ring 1602 (inits annular operable geometry) has been changed to be perpendicular tothe longitudinal axis of the delivery catheter 1614. As shown in FIG.16D, the superelastic ring deployment wire 1623 has returned to its heatset (memorized) straight configuration. At this fourth stage ofdeployment, the plane of the annuloplasty ring 1602 is configured to beparallel to the plane of the heart valve annulus. In situ within theheart, a longitudinal axis of the delivery catheter 1614 is orientedparallel to the direction of blood through the valve and approximatelyperpendicular to the plane of the heart valve. The annuloplasty ring1602, when oriented such that the plane of the annuloplasty ring 1602 istransverse to (and perpendicular or approximately perpendicular to) thelongitudinal axis of the delivery catheter 1614, is oriented such thatthe plane of the annuloplasty ring 1602 is parallel or approximatelyparallel to the plane of the heart valve.

In further stages of deployment, the annuloplasty ring 1602 may beexpanded and/or pressed against the heart valve annulus before deployingthe anchors (such as the curved anchors 104 shown in FIGS. 1A and 1B).As discussed above, certain anchor embodiments propel themselves intothe tissue of the heart valve annulus upon being deployed. In otherembodiments, the anchors (such as the linear anchors 1340 shown in FIG.13) may be deployed before pressing the annuloplasty ring 1602 againstthe annulus. After the annuloplasty ring 1602 is anchored to the heartvalve annulus and transitioned to the contracted state, the ringdeployment wire 1623 may be pulled from the hole in the pivot 1608 torelease the annuloplasty ring 1602 from the ring shuttle 1616. Anyremaining sutures, such as the first suture 1619, may also be cut and/orpulled from the annuloplasty ring 1602 before the delivery catheter 1614is removed from the heart.

FIG. 17A is a flowchart of a method 1700 for repairing a defective heartvalve according to one embodiment. The method 1700 includespercutaneously introducing 1710 a distal end of a first catheter into aleft atrium of a heart and inserting 1712 an annuloplasty ring, attachedto a second catheter, through the first catheter into the left atrium.The ring includes a superelastic shape memory material that transformsthe ring from an elongate insertion geometry to an annular operablegeometry as the ring exits the distal end of the first catheter. Themethod 1700 further includes rotating 1714 the ring to change a plane ofthe ring from a first direction that is parallel to the second catheterto a second direction that is parallel to a plane of the mitral valveannulus, and pulling 1716 a first suture, connected to the ring throughthe second catheter, to couple the ends of the ring together. The method1700 includes inserting 1718 an expansion device through the firstcatheter into the left atrium and activating the expansion device topress the ring against the valve annulus. Then, pulling 1720 a secondsuture, connected to the ring through the second catheter, to deploy aplurality of tissue anchors from the ring into the surrounding tissue.In some embodiments, the step 1720 of deploying anchors comprisesretracting a retaining ribbon from across the anchors thereby causingthe anchors to deploy as described above in relation to FIGS. 4A, 4B,4C, 4D, and 4F. In other embodiments, the step 1720 of deploying anchorscomprises rotating an inner tube within an outer cover thereby causingthe anchors to deploy through windows in the outer cover as describedabove in relation to FIGS. 5A, 5B, 5C, and 5D. The method 1700 furtherincludes detaching 1722 the ring from the second catheter and the firstand second sutures, and remove the first and second catheters from theheart.

FIG. 17B is a flowchart of a method 1730 for repairing a defective heartvalve according to another embodiment. The method 1730 includespercutaneously introducing 1732 a distal end of a first catheter into aleft atrium of a heart, and inserting 1734 a segmented annuloplastyring, attached to a second catheter, through the first catheter into theleft atrium. The ring includes superelastic shape memory material thattransforms the ring from an elongate insertion geometry to an annularoperable geometry as the ring exits the distal end of the firstcatheter. The method 1730 further includes automatically rotating 1736the ring to change a plane of the ring from a first direction that isparallel to the second catheter to a second direction that is parallelto a plane of the mitral valve annulus, and inserting 1738 an expansiondevice through the first catheter into the left atrium and activatingthe expansion device to press the ring against the valve annulus.Pressing the ring against the annulus at this stage allows thesubsequent deployment of the anchors to propel the anchors into theannulus tissue. Thus, the method 1730 further includes pulling 1740 afirst suture, connected to the ring through the second catheter, todeploy a plurality of tissue anchors from the ring. Each of theplurality of anchors includes a superelastic shape memory material thatpropels the superelastic anchors into the tissue of the valve annulus.In some embodiments, the step 1740 of deploying anchors comprisesretracting a retaining ribbon from across the anchors thereby causingthe anchors to deploy as described above in relation to FIGS. 4A, 4B,4C, 4D, and 4F. In other embodiments, the step 1740 of deploying anchorscomprises rotating an inner tube within an outer cover thereby causingthe anchors to deploy through windows in the outer cover as describedabove in relation to FIGS. 5A, 5B, 5C, and 5D. The method 1730 furtherincludes pulling 1742 a second suture, connected to the ring through thesecond catheter, to couple the ends of the ring together and cinch thevalve annulus to a desired size. The method 1730 also includes detaching1744 the ring from the second catheter and the first and second sutures,and removing the first and second catheters from the heart.

FIG. 18 is a flowchart of a method 1800 for repairing a defective heartvalve according to one embodiment. The method 1800 includespercutaneously introducing 1810 a distal end of a first catheter into aleft atrium of a heart and inserting 1812 an annuloplasty ring, attachedto a second catheter, through the first catheter into the left atrium.The ring includes a superelastic shape memory material that transformsthe ring from an elongate insertion geometry to an annular operablegeometry as the ring exits the distal end of the first catheter. Themethod 1800 further includes rotating 1814 the ring to change a plane ofthe ring from a first direction that is parallel to the second catheterto a second direction that is parallel to a plane of the mitral valveannulus, and pulling 1816 a first suture, connected to the ring throughthe second catheter, to couple the ends of the ring together. The method1800 includes inserting 1818 an expansion device through the firstcatheter into the left atrium and activating the expansion device topress the ring against the valve annulus. Next, pulling 1820 a secondsuture, connected to the ring through the second catheter, to deploy afirst set of tissue anchors from the ring into the surrounding tissue.The method includes pulling 1822 a third suture, also connected to thering through the second catheter, to deploy a second set of tissueanchors oriented in a direction opposite (anti-parallel) from the firstset of anchors into the surrounding tissue. The method 1800 may alsoinclude pulling additional sutures, also connected to the ring throughthe second catheter, to deploy additional sets of tissue anchors,located on additional anchor regions of the annuloplasty ring, into thesurrounding tissue. In some embodiments, three sets of anchors aredeployed; each set of anchors attached to an internal anchor ribbon anddeployed using a separate suture. In addition, or in other embodiments,the method 1800 may also include pulling another suture, connected tothe ring through the second catheter, to couple the ends of the ringtogether. The method 1800 further includes detaching 1824 the ring fromthe second catheter and the first, second, and third sutures, and removethe first and second catheters from the heart.

Those having skill in the art will understand from the disclosure hereinthat many changes may be made to the details of the above-describedembodiments without departing from the underlying principles of theinvention. The scope of the present invention should, therefore, bedetermined only by the following claims.

1. An annuloplasty device for transcatheter heart valve repair, theannuloplasty device comprising: an outer tube comprising a plurality ofwindows, the outer tube including an axis along its length; an internalbody member within the outer tube, the internal body member comprising aplurality of anchors; and an anchor deployment system to selectivelyrotate the internal body member with respect to the axis of the outertube, the rotation deploying the plurality of anchors through theplurality of windows.
 2. The annuloplasty device of claim 1, wherein theanchor deployment system comprises a wire configured to percutaneouslyrotate the internal body member.
 3. The annuloplasty device of claim 1,wherein the internal body member comprises a hollow passage and one ormore tabs extending from a surface of the hollow passage, and whereinthe anchor deployment system comprises: a rotation member configured tobe pushed or pulled through the hollow passage of the internal bodymember by a line connected to the rotation member through a catheter,the rotation member to convert linear movement of the line through thecatheter into rotation of the internal body member.
 4. The annuloplastydevice of claim 3, wherein the rotation member comprises: a threadedgroove along an outer surface of the rotation member, the threadedgroove to engage the one or more tabs and rotate the internal bodymember as the rotation member is pushed or pulled through the hollowpassage.
 5. The annuloplasty device of claim 1, wherein the plurality ofanchors comprise a superelastic shape memory material configured toself-propel the anchors into tissue of a heart valve annulus whenrespective tips of the plurality of anchors are aligned with theplurality of windows.
 6. The annuloplasty device of claim 5, wherein theplurality of anchors comprise: an introduction configuration forinserting the annuloplasty device through a catheter, wherein theplurality of anchors in the introduction configuration are curved in afirst direction so as to be concentric with a surface of the internalbody member with respect to the axis; and a deployed configuration forattaching the annuloplasty device to the tissue of the heart valveannulus, wherein the plurality anchors in the deployed configuration arecurved in a second direction that is opposite to the first direction, atransition from the first direction to the second direction increasing aforce of the superelastic material for driving the plurality of anchorsinto the tissue.
 7. The annuloplasty device of claim 1, wherein at leastone of the outer tube and the internal body member comprises asuperelastic shape memory material configured to change from an elongateinsertion geometry to an annular operable geometry, the annuloplastydevice configured to pass through a catheter and into a heart chamber inthe elongate insertion geometry.
 8. The annuloplasty device of claim 1,wherein at least two of the plurality of windows are aligned on theouter tube to substantially simultaneously deploy at least twocorresponding anchors of the plurality of anchors.
 9. The annuloplastydevice of claim 1, wherein at least two of the plurality of windows arealigned on the outer tube to selectively deploy at least twocorresponding anchors of the plurality of anchors at different times.10. The annuloplasty device of claim 1, wherein one or more of theplurality of anchors include a shape selected from a group comprisingcurved, wavy, straight, and curled.
 11. The annuloplasty device of claim1, wherein one or more of the plurality of anchors include a pattern cuttherein to control at least one of strength and flexibility, the patternselected from a group comprising a series of rounded rectangularcutouts, a plurality of wavy cutouts, and one or more slots cut along ananchor length. 12-14. (canceled)
 15. An annuloplasty ring fortranscatheter heart valve repair, the annuloplasty ring comprising: anouter hollow member configured to change from an elongate insertiongeometry to an annular operable geometry, the outer hollow membercomprising a plurality of windows; a first internal anchor memberlocated at least partially within the outer hollow member, the firstinternal anchor member comprising a plurality of first anchorsconfigured to attach the annuloplasty ring to tissue of a heart valveannulus, the first internal anchor member configured to move theplurality of first anchors with respect to corresponding windows of theplurality of windows in the outer hollow member to selectively deploythe plurality of first anchors through the corresponding windows; and asecond internal anchor member located at least partially within theouter hollow member, the second internal anchor member comprising aplurality of second anchors configured to attach the annuloplasty ringto the tissue of the heart valve annulus, the second internal anchormember configured to move the plurality of second anchors with respectto corresponding windows of the plurality of windows in the outer hollowmember to selectively deploy the plurality of second anchors through thecorresponding windows.
 16. The annuloplasty ring of claim 15, whereinthe plurality of first anchors and the plurality of second anchors areconfigured to deploy at substantially the same time.
 17. Theannuloplasty ring of claim 15, wherein the plurality of first anchorsand the plurality of second anchors are configured to selectively deployat different times.
 18. The annuloplasty ring of claim 15, wherein theplurality of first anchors curve in a first direction in a deployedconfiguration, and the plurality of second anchors curve in a seconddirection in the deployed configuration, the second direction beingdifferent than the first direction.
 19. The annuloplasty ring of claim18, wherein the plurality of first anchors are each adjacent to acorresponding one of the plurality of second anchors in the deployedconfiguration.
 20. The annuloplasty ring of claim 19, wherein adjacentanchors deploy through a same window of the plurality of windows. 21.The annuloplasty ring of claim 19, wherein adjacent anchors deploythrough separate, adjacent windows of the plurality of windows.
 22. Theannuloplasty ring of claim 15, wherein at least one of the plurality offirst anchors and one of the plurality of second anchors include a shapein a deployed configuration selected from a group comprising curved,wavy, straight, and curled. 23-28. (canceled)